Actively Recruiting
BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System
Led by Biotronik, Inc. · Updated on 2026-04-06
325
Participants Needed
2
Research Sites
56 weeks
Total Duration
On this page
Sponsors
B
Biotronik, Inc.
Lead Sponsor
B
Biotronik SE & Co. KG
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the LivIQ leadless pacemaker system in patients who need ventricular pacing (VVI or VDD) according to clinical guidelines. This study aims to confirm the safety and performance of this device, including a special sub-study focusing on atrioventricular synchrony (AVS) performance. The trial is open-label, prospective, and involves multiple centers internationally, enrolling 325 participants. Participants will receive the LivIQ system, a single-chamber leadless pacemaker implanted directly into the right ventricle. The study involves a single arm where all subjects receive the device. The AVS sub-study collects specific data on AV synchrony using Holter monitors at 1 and 6 months. Follow-up visits are scheduled at implant, pre-discharge, 1 month, 3 months, 6 months, 12 months, then every 6 months until market approval. After U.S. approval, a remote 24-month visit will check vital status. During the study, participants undergo on-site exams, device performance checks, and questionnaires measuring quality of life and physical function. Researchers will monitor serious adverse device effects, pacing and sensing adequacy, battery longevity, and survival rates. The total participation will last until market approval with ongoing follow-up visits to ensure comprehensive safety and performance assessments.
CONDITIONS
Brief Title
BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Class I or Class II indication for ventricular pacing (VVI/VDD) according to applicable guidelines
- Age 18 years or older at time of consent
- Able to understand the study and provide written informed consent
- Willing and able to complete all study visits for the duration of follow-up
You will not qualify if you...
- AV block with ventricular escape rhythm 30 bpm or less at consent (restriction removed after early safety phase)
- Femoral venous or cardiac anatomy unsuitable for leadless pacemaker implantation
- Morbid obesity preventing telemetry communication within 20 cm range
- Intolerance to dexamethasone acetate
- Other implanted devices interfering with the pacemaker or procedure
- Allergy to materials of the pacemaker or implant tools
- Prior leadless pacemaker implant attempt
- Existing pacemaker, ICD, CRT device, or previous lead extraction with leads left in heart (except temporary transvenous pacemakers)
- Device extraction within 72 hours or active infection signs after extraction
- Planned ICD or CRT device implant
- Unstable angina or acute myocardial infarction within 30 days before enrollment
- Life expectancy less than 12 months
- Unable to tolerate urgent sternotomy
- Planned right-sided heart intervention within 30 days after implant (except certain AV nodal ablations)
- Listed for or received heart transplant or has LVAD
- Participation in other conflicting investigational trials without approval
- Unable to attend in-person study visits
- Pregnant or planning pregnancy during study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single procedure with immediate post-implant assessment
Participants receive a single-chamber leadless pacemaker system implanted directly into the right ventricle.
1 implant visit and 1 pre-hospital discharge visit
Duration - Up to 12 months with continued in-person follow-up every 6 months until regional market approval
Participants are followed in-person at multiple time points to assess device performance and health outcomes.
Visits at 1 month, 3 months, 6 months, 12 months, and every 6 months thereafter
Duration - At 24 months post-implant
After U.S. market approval, participants have a remote 24-month visit to assess vital status.
1 remote visit
Trial Site Locations
Total: 2 locations
1
Kokura Memorial Hospita
Kitakyushu, Fukuoka, Japan, 802-8555
Actively Recruiting
2
National Cerebral and Cardiovascular Center Hospital
Suita, Osaka, Japan, 564-8565
Actively Recruiting
Research Team
J
Jennifer Alkire Project Manager
A
Andreas Peth Clinical Project Manager
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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